The requirements of the EUDAMED and its six modules can quickly become confusing for its users, as can the maintenance of data. However, with the implementation date approaching, it is important to know how they will be implemented and which tools will help. Our free Excel template for EUDAMED will help to simplify your work and shows which product data is mandatory to report and which is optional.
Once EUDAMED is fully operational with all modules, manufacturers must submit their product data. Smaller producers of medical devices have to expect a considerable amount of work to meet the requirements. Good preparation for this point in time is therefore particularly important. After all, working with EUDAMED is not a one-time project but an ongoing process and will require attention in the future as well.
What can the Excel template help with?
- Pre-sorting the product data
- Exporting data from your own ERP and then sorting it in the Excel spreadsheet for less manual work
- Close gaps – where is data still missing?
- Identify which information is mandatory for each product type
- EUDAMED compliant preparation of your data
- Data is clearly prepared in Excel so that there are no difficulties in entering it into EUDAMED, and you have all data in one central point
After the data has been prepared, it still needs to find its way into EUDAMED. There are three different ways for manufacturers to upload their processed product data into it:
- through EUDAMED’s own user interface – here the data input is done manually.
- via XML files – by means of an XML bulk upload, up to 200 individual data sets can be reported collectively to EUDAMED, but the XML file must be generated beforehand.
- with M2M Data Exchange – here an interface between EUDAMED and end-users is established, which automatically transmits the data to EUDAMED after entry. Any number of data sets can be transmitted at the same time.
How to use the tracekey Excel template
- Support for data maintenance
- Manage entered data centrally to simplify transfer to EUDAMED
- Show which data and attributes I need for my UDIs
- Show which entries are mandatory and which are optional
- Facilitate the whole process and serves as an optimal preparation for the deadlines
- In addition, it allows you to prepare for M2M connection with our software solution mytracekey MedTech
Download: Excel template